DermatitisNCT06850389
PMCF Investigation of Medical Device ChitoCare® Medical
An observational study of Dermatitis and Acne, run by Primex ehf at 2 sites in Czechia.
Trial summary
This is a post-marketing observational clinical investigation conducted as part of the post-market clinical follow-up of ChitoCare® Medical, aimed to confirm safety and efficacy according to the requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dermatitis, Acne, Conditions After Dematosurgical Procedures
- What is being tested?
- ChitoCare® medical Wound Healing Gel and ChitoCare® medical Healing Spray
- Type of treatment
- Medical device
- How many people
- 214 participants
- Where
- 2 sitesCzechia
- Study dates
- 11 Jun 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: The device is intended for use in all age groups, including children and the elderly. All participants who fulfill the inclusion and exclusion criteria will be considered for enrollment.
The inclusion criteria are fully according to indications:
- Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne
- Spray - conditions after dermatosurgical procedures, dermatitis, acne
The criteria for exclusion are fully according to contraindications:
- Allergy to any of the ingredients of the product
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia2 sites, 2 recruiting
- Recruiting
Dermatovenerology department, FN Motol
Prague, 15006
Alena Machovcová,, MD, +420 224 438 770, alena.machovcova@fnmotol.cz
- Recruiting
Dermatology of Prof. Hercogova
Prague, 18100
Jana Třešňák Hercogová,, MD, +420 246 035 111, recepce@euderma.cz
About this study
This is a post-marketing observational clinical investigation conducted as part of the post-market clinical follow-up of ChitoCare® Medical, aimed to confirm safety and efficacy according to the requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, for the following indications:
Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne
Spray - conditions after dermatosurgical procedures, dermatitis, acne
- Conditions
- Dermatitis, Acne, Conditions After Dematosurgical Procedures, Scars
- Being tested
- ChitoCare® medical Wound Healing Gel, ChitoCare® medical Healing Spray
- Medical subject headings
- Dermatitis, Acne Vulgaris, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChitoCare® medical Wound Healing GelDevice
ChitoCare® medical Wound Healing Gel is a medical device containing ChitoClear® chitosan. The device is indicated for the treatment of acute and chronic wounds and other skin conditions, including partial thickness burn wounds.
ChitoCare® medical Healing SprayDevice
ChitoCare® medical Healing Spray is a medical device containing ChitoClear® chitosan. The device is indicated for the treatment of acute wounds and other skin conditions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant improvement in Vancouver Scar Scale (VSS)
For scars and conditions after dermatosurgical procedures, efficacy is defined as a significant improvement in Vancouver Scar Scale (VSS) scores from baseline after 3 months of treatment.
Measured: 3 months
Significant improvement in Comprehensive Acne Severity Scale (CASS)
For acne, efficacy is defined as a significant improvement in the severity rating of patients' acne using the Comprehensive Acne Severity Scale (CASS) from baseline after 2 months of treatment.
Measured: 2 months
Significant improvement in dermatitis severity scale
For dermatitis, efficacy is defined as a significant improvement in the severity dermatitis severity scale after 2 months of treatment.
Measured: 2 months
Secondary outcomes (4)
Confirmation of safety (adverse events)
Safety will be confirmed when less than 5% of subjects report an adverse event when all participants have completed the trial.
Measured: 2-3 months
Confirmation of safety (serious adverse events)
Safety will be confirmed when less than 1% of subjects report a serious adverse event when all participants have completed the trial.
Measured: 2-3 months
Quality of life assessment (adults)
Quality of life will be assessed in adults using the Dermatology Life Quality Index (DLQI) questionnaire. Improvements in quality of life from baseline will be reported.
Measured: 2-3 months
Quality of life assessment (children)
In children, quality of life will be assessed using the pediatric version of the Dermatology Life Quality Index - the Childhood Dermatology Life Quality Index (CDLQI) questionnaire. Improvements in quality of life from baseline will be reported.
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start11 Jun 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Primex ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Porta Medica
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850389
- Sponsor's protocol ID
- CHITODERM
- Status last verified
- Aug 2025
- First submitted
- 18 Feb 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PMCF Investigation of Medical Device ChitoCare® Medical
- ClinicalTrials.gov ID
- NCT06850389
- Acronym / sponsor ID
- CHITODERM
- Conditions
- Dermatitis, Acne, Conditions After Dematosurgical Procedures, Scars
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Primex ehfIndustry (pharma, biotech, devices)
- Collaborators
- Porta Medica
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a post-marketing observational clinical investigation conducted as part of the post-market clinical follow-up of ChitoCare® Medical, aimed to confirm safety and efficacy according to the requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, for the following indications:
Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne
Spray - conditions after dermatosurgical procedures, dermatitis, acne
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The device is intended for use in all age groups, including children and the elderly. All participants who fulfill the inclusion and exclusion criteria will be considered for enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChitoCare® medical Wound Healing GelChitoCare® medical Wound Healing Gel is a medical device containing ChitoClear® chitosan. The device is indicated for the treatment of acute and chronic wounds and other skin conditions, including partial thickness burn wounds. | Device | – |
| ChitoCare® medical Healing SprayChitoCare® medical Healing Spray is a medical device containing ChitoClear® chitosan. The device is indicated for the treatment of acute wounds and other skin conditions. | Device | – |
Primary outcome
Significant improvement in Vancouver Scar Scale (VSS)
Time frame: 3 months
For scars and conditions after dermatosurgical procedures, efficacy is defined as a significant improvement in Vancouver Scar Scale (VSS) scores from baseline after 3 months of treatment.
Significant improvement in Comprehensive Acne Severity Scale (CASS)
Time frame: 2 months
For acne, efficacy is defined as a significant improvement in the severity rating of patients' acne using the Comprehensive Acne Severity Scale (CASS) from baseline after 2 months of treatment.
Significant improvement in dermatitis severity scale
Time frame: 2 months
For dermatitis, efficacy is defined as a significant improvement in the severity dermatitis severity scale after 2 months of treatment.
4 secondary outcomes
Confirmation of safety (adverse events)
Time frame: 2-3 months
Confirmation of safety (serious adverse events)
Time frame: 2-3 months
Quality of life assessment (adults)
Time frame: 2-3 months
Quality of life assessment (children)
Time frame: 2-3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis and Acne, run by Primex ehf at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Craig Fraser, PhD (+354 846 1912, craig@chitocare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant improvement in Vancouver Scar Scale (VSS) (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.